TB IgG/IgM Combo Rapid Test CE
Features:
A lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM and IgG anti-Mycobacterium tuberculosis (anti-M. TB) in human serum, plasma or whole blood.
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Plastic droppers
- Sample diluent (REF SB-R0053, 5 mL/bottle)
- One package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0053C |
TB IgG/IgM Combo Rapid Test CE |
30/kit |
S, P &WB |
TORCH Panel Rapid Test
Features:
-
- Distinguishes between IgG and IgM in all five TORCH infections
- Compatible with serum, plasma, and whole blood
- Results available in 15 minutes
- Provides semi-quantitative results for Rubella IgG antibodies
- Distinguishes between HSV-1 and HSV-2
- Shelf life: 18 months
- Analytical Sensitivity of IgG Detection: Twenty negative specimens were spiked with appropriate reference standards at various concentrations. Specimens were run on the OnSite TORCH Panel Rapid Test panel member. Defined as the 95% detection level, the limits of detection, or sensitivity, were determined to be as follows:
- Toxo: 5 IU/mL LOD; WHO International Standard Anti-Toxoplasma Serum Ig (TOXM)
- Rubella: 15 IU/mL (G1); 250 IU/mL (G2); WHO 1st International Standard (RUBI-1-94)
- Accuracy of IgG Detection in comparison with commercial ELISA: Clinical IgG positive specimens were collected and tested on each OnSite TORCH Panel Rapid Test panel member as well as by commercial ELISA. Comparison for all subjects showed the following overall agreements:
- Toxo (237 specimens): 94.9%
- Rubella (214 specimens): 97.7%
- CMV (258 specimens): 93.4%
- HSV-1 (227 specimens): 90.7%
- HSV-2 (214 specimens): 95.3%
- Accuracy of IgM Detection in comparison with commercial ELISA: Clinical IgM positive specimens were collected and tested on each OnSite TORCH Panel Rapid Test panel member as well as by commercial Comparison for all subjects showed the following overall agreements:
- Toxo (231 specimens): 98.8%
- Rubella (25 specimens): 96.0%
- CMV (212 specimens): 93.9%
- HSV-1 (107 specimens): 85.0%
- HSV-2 (26 specimens): 95.2%
- Cross Reactivity: No false positive IgG and IgM results were observed on 3-14 specimens from the following disease states or special conditions, respectively: Toxo, Rubella, CMV, HSV-1, HSV-2, hCG, HAV, HBV, HCV, HEV, HIV, TB, palladium, Dengue, Malaria, H. pylori, Typhoid, ANA, HAMA, and RF (>1,000 IU/mL).
During cross-reactivity testing for each TORCH infection, self-reactivity was not considered (i.e. rubella positive samples were not tested on the Rubella IgG/IgM Rapid Test). Specimens tested vary for each panel member of the OnSite TORCH Panel Rapid Test.
- Interference: No interference was seen from the following substances: Albumin 60 g/L; Bilirubin 20 mg/dL; Heparin 3,000 U/L; Hemoglobin 2 g/L; Creatinine 442 µmol/L; EDTA 3.4 µmol/L; Salicylic acid 4.34 mmol/L; Glucose 55 mmol/L; and Sodium citrate 3.8%.
- Individually sealed foil pouches containing:
- One cassette device
- Two desiccants
- Plastic droppers
- Sample diluent (REF SB-R0253, 5 mL/bottle)
- One package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0253C |
TORCH Panel Rapid Test |
10/kit |
S,P& WB |
Toxo IgG/IgM Combo Rapid Test
Features:
- A lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-Toxoplasma gondii (T. gondii) in human serum, plasma or whole blood.
-
- Individually sealed foil pouches containing:
a. One cassette device
b. One desiccant
- 10 µL capillary tubes
- Sample diluent (REF SB-R0234, 5 mL/bottle)
- One package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0234C |
Toxo IgG/IgM Combo Rapid Test |
30/kit |
S, P &WB |
Troponin I Combo Rapid Test CE
Features:
- Clinical performance:
- Relative Sensitivity: 95.8% (95% CI: 91.5-97.9%) compared to a reference CLIA
- Relative Specificity: 99.7% (95% CI: 98.8-99.9%)
- Analytical sensitivity: The detection limit of cTnI is 1.0 ng/mL or greater in serum, plasma or whole blood specimen
- Cross-reactivity: No cross reactivity with 10 µg/mL skeletal muscle TnI, 2,000 ng/mL cardiac muscle TnT, 20 µg/mL cardiac muscle Myosin
- Dose hook effect: No hook effect was observed for cTnI at concentrations up to 3,521 µg/mL
- Interference: No interference was seen with 20 mg/dl Acetaminophen, 20 mg/dl Acetylsalicylic acid, 10.5 g/dl Albumin, 20 mg/dl Ascorbic acid, 1,000 mg/dl Bilirubin, 20 mg/dl Caffeine, 800 mg/dl Cholesterol, 200 mg/dl Creatinine, 20 mg/dl Gentistic acid, 1,000 mg/dl Hemoglobin, 600 mg/dl Oxilic acid, 1,600 mg/dl Triglycerides
- Shelf life: 24 months
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Plastic droppers
- Sample diluent (REF SB-R3002, 5 mL/bottle)
- One package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTOTY | SPECIMEN |
R3002C |
Troponin I Combo Rapid Test CE |
30/kit |
S, P & WB |
Typhoid IgG/IgM Combo Rapid Test CE
Features:
- Utilizes O antigen and H antigen from both typhi and paratyphi serovars to maximize sensitivity
- Differentiates between IgG and IgM to determine stage of infection
- One step procedure minimizes operator error due to sample preparation
- Test result within 15 minutes allows medical professionals to take immediate action
- High level of reproducibility
- Test kits can be used and stored in a wide range of temperatures
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Plastic droppers
- Sample Diluent (REF SB-R0161, 5 mL/bottle)
- Package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTOTY | SPECIMEN |
R0161C |
Typhoid IgG/IgM Combo Rapid Test |
30/kit |
S,P &WB |